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From Ortho-McNeil

November 12, 2004

Topomax Tablets- New for Migraine Prevention

Dear RxLink Pharmacist:

I am pleased to inform you that TOPOMAX is now approved for migraine prevention. TOPOMAX Tablets and TOPOMAX Sprinkle Capsules are indicated for adults for the prophylaxis of migraine headaches. The usefulness of TOPOMAX in the acute treatment of migraine headache has not been studied. The efficacy and safety of TOPOMAX were established in 2 large, 26 week, randomized, double-blind, placebo-controlled clinical trials. In fact, these studies are the largest controlled trials conducted to this date for migraine prevention.

Powerful efficacy in the [prevention of migraine

TOPOMAX 50 mg BID (100mg/day) significantly reduced migraine frequency by 2.1 migraines per month in 2 pivotal trials vs. 0.8 (P<0.001 and 1.1 (P<0.008) for placebo, respectively (baseline of approximately 5.5 migraines per month).

Proven tolerability profile

The most common adverse event was paresthesia; however, most patients rated its severity as mild to moderate and discontinuation due to this effect was 7%. The most common adverse events associated with TOPOMAX 100 mg vs. placebo were: parasthesia, 51% vs. 6%; anorexia 15% vs. 6%; fatigue 15% vs. 11%; nausea, 13 % vs. 8%; diarrhea, 11% vs. 4%; weight decrease, 9% vs. 1%; and taste alteration 8% vs. !%. Of the 1135 patients exposed to topiramate in the placebo-controlled studies, 25% discontinues due to adverse events, compared to 10% of the 445 placebo patients.

Established safely profile

Clinical trials included more than 1700 patients. The only contraindication with TOPOMAX is in patients having history of hypersensitivity to any component of this product. TOPOMAX is not associated with significant drug-drug interactions with sumatriptan, propranolol, or dihydroergotamine. TOPOMAX is not associated with an increase incidence of impotence, hypotension, or urinary retention vs. placebo. Please see important Safety Information on next page.

The recommended target maintenance dose for migraine prevention is 50 mg BID

It is recommended that TOPOMAX be initiated at a dose of 25 mg/day, followed by titration in weekly increments of 25 mg/day to the recommended target maintenance dose of 50 mg BID. Dose and titration should be guided by clinical outcome. If required, longer intervals between dosage adjustments can be used. TOPOMAX can be taken with and without food.

Important Safety Information

TOPOMAX has been associated with serious adverse events, including: Hyperchloremic, non-anion gap metabolic acidosis-lowering of bicarbonate levels in the blood. Measurement of baseline and periodic serum bicarbonate is recommended. Acute myopia and secondary angle-closure  glaucoma-patients should be cautioned to seek medical attention if they experience blurred vision or ocular pain. Oligohidrosis and hyperthermia-decreased sweating and increased body temperature, especially in hot weather. The majority of reports have been in children. Cognitive/psychiatric side effects, including cognitive dysfunction,  psychiatric/behavioral disturbance, and somnolence and fatigue.

The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patents taking combination oral contraceptive products with TOPOMAX.

Patients should be instructed to maintain an adequate fluid intake in order to minimize the risk of renal stone formation.

Please see accompanying full Prescribing Information.

Thank you for taking time to learn about TOPOMAX for migraine prevention. Please visit www.topomax.com or call 1-877-323-2200 for more information.

Sincerely, Joseph Hulihan, MD

Vice president, Medical Affairs

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